MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number FG-0202

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Manufacturer: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory was used during hysteroscopy myomectomy procedure performed on (b)(6) 2017.According to the complainant, three 3-liter saline bags were utilized during procedure; two saline bags were completely consumed and the third saline was partially consumed, which caused an over 2500 ml approximately fluid deficit loss inside the patient.The symphion system ifu ((b)(4)) states that the symphion system is designed for use with a single 2 liter or 3 liter irrigation usp saline bag.Use a single 2 liter or 3 liter irrigation ups saline bag only.Do not use multiple saline bags.Use of multiple saline bags increases the chance of fluid overload.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.The patient was discharged.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6882452
• MDR Text Key: 87159082
• Report Number: 3005099803-2017-02906
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG-0202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other